Kornimate/medical-research-clean huggingface dataset:
pilot study to evaluate the effect of two microalgae consumption on metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to evaluate the effect of the consumption of two microalgae chlorella vulgaris and arthrospira platensis (spirulina) on some biomarkers of metabolic syndrome: total cholesterol, hdl cholesterol, ldl cholesterol, triglycerides, apolipoprotein a and apolipoprotein b, in overweight / obese subjects with altered lipid profile.

a randomized, parallel, and double-blind pilot study with 3 study arms is being performed to evaluate the effect of the consumption of two unicellular microalgae: chlorella vulgaris and arthrospira platensis (spirulina). the investigators included 30 participants between 18 and 65 years (bmi ≥25 and \<40 kg / m2). all volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products during 30 days.

Eligibility criteria:
inclusion criteria: * men and women from 18 to 65 years old. * body mass index (bmi) ≥25 and \<40 kg/m2. * cardiovascular risk \<10% * adequate cultural level and understanding * agree to participate in the study exclusion criteria: * subjects with bmi ≥40 or \<25 kg /m2 * subjects diagnosed with diabetes mellitus. * subjects with dyslipidemia on pharmacological treatment * subjects with hypertension on pharmacological treatment * subjects with established diagnosis of eating disorder * smokers or those subjects with high alcohol consumption * subjects under pharmacological treatment * subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet * subjects with sensory problems * subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients * pregnant or breastfeeding women * women with menstrual irregularities * subjects with intense physical activity * subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption * subjects with a diagnosis of celiac disease or a gluten intolerance

Keywords: microalgae lipid profile metabolic syndrome pilot
measuring blood flow in heart vessels with a new fibre optic sensor

Conditions: Coronary Artery Disease; Coronary Stenosis; Coronary Microvascular Disease

Summary: the purpose of this investigation is to see if the newly developed "ikos™ microcatheter" can safely and accurately measure flow and pressure within the heart arteries of 10 patients undergoing angiogram and pressure wire tests.

after being informed about the study and the potential risks and benefits, participants who provide written consent will be screened to make sure they fulfil the study entry requirements. those who are assessed as eligible will undergo baseline assessments and preparation for their angiogram. once enrolled they will undergo coronary angiography at the start of their clinical procedure. the angiogram will be examined by the investigator and a decision made if the target vessel is suitable for a pressure wire study and insertion of the investigational device. if the investigator confirms that the participant remains eligible and the study part can go ahead, the participant will proceed to undergo the investigation with the ikos microcatheter. the study assessments will be performed through the right radial artery (preference) under local anaesthesia. a sheath will be inserted and a pre-procedure blood sample taken for troponin t level. a pressure study will then be performed, initially with a pressure wire before using the ikos™ microcatheter. both will be performed before and after hyperaemia. following withdrawal of the ikos™ microcatheter, a pressure wire assessment is then repeated after the microcatheter is withdrawn. the case will then proceed as clinically indicated. the whole procedure should take about 30-45 minutes. post-procedure the participant will be managed according to standard clinical practice. the participant will be discharged home, usually about 4 hours after the end of the procedure. a troponin blood test and ecg will be repeated before they are discharged. follow up telephone calls to assess for any complications of the procedure will be made within the first 7 days and again between 6 and 8 weeks after the procedure.

Eligibility criteria:
inclusion criteria: * able and willing to give informed consent * \>18 years old * have a clinical diagnosis of coronary artery disease * undergoing further assessment of a coronary artery with a pressure wire study exclusion criteria: general * previous coronary artery bypass grafting. * non/st-elevation myocardial infarction as indication for angiography. * ongoing evidence of ischaemia at rest. * severe renal impairment (gfr \<25). * severe anaemia (hb \<10). * heparin allergy. * atrial fibrillation. * contraindication to adenosine. * pregnant or lactating; or female of childbearing potential. * participation in other interventional studies. additional exclusion criteria at angiogram: * critical coronary artery stenosis in the vessel which is to be studied (\>90%). * left main stem coronary disease causing a \>50% stenosis. * triple vessel coronary disease.

Keywords: heart microcatheter fibreoptic
a monotherapy study to evaluate the efficacy and safety of 2 dose levels of albiglutide in japanese subjects with type 2 diabetes mellitus (t2dm)

Conditions: Diabetes Mellitus, Type 2

Summary: this study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in japanese subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * subjects with diagnosis of type 2 diabetes mellitus, treated with diet and exercise or a stable dose of 1 oad at screening * body mass index (bmi) 17 to 40 kg/ m\^2 inclusive * subjects who are oad naïve, hba1c between 7.0% and 10.0% at screening and at visit 2; for subjects who enter the study with 1 oad, hba1c between 6.5% and 9.5% at screening and hba1c between 7.0% and 10.0% at visit 2 * creatinine clearance \>30 ml/min (calculated using the cockcroft-gault formula) exclusion criteria: * history of type 1 diabetes mellitus •female subject is pregnant, lactating, or \<6 weeks postpartum• * clinically significant cardiovascular and/or cerebrovascular disease * current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator * serum amylase \>=3 ×uln and/or serum lipase \>=2 × uln and/or subject is experiencing any symptoms possibly related to pancreatitis * prior use of a tzd or glp-1r agonist within 4 months before screening

Keywords: albiglutide japanese gsk716155 type 2 diabetes mellitus glucagon-like peptide 1
venous obstruction in neurodegenerative disorders research registry

Conditions: Chronic Cerebral Spinal Venous Insufficiency

Summary: to establish if there are venous obstructions in patients with neurodegenerative disorders

this research registry will observe the venous obstruction in neurodegenerative disorders. this will provide data that will allow researchers to classify abnormal valve and venous morphology, distinguish vessels which are more responsive to treatment, determine groups who respond more favorably to treatment, and overall evaluate the outcomes of venous angioplasty in various neurodegenerative disorders that involve venous obstruction.

Eligibility criteria:
inclusion criteria: * ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent * males or females between the ages of 18 and 90 years of age * voluntary agreement to participate in the venous obstructions in neurodegenerative diseases research registry exclusion criteria: * any implantable/metallic objects that prevent subject from having a magnetic resonance imaging ( mri/mrv) study * history of uncontrolled hypertension * previous venous angioplasty treatment for chronic cerebral spinal venous insufficiency * special populations. special groups include, but are not limited to children, prisoners, pregnant women,fetuses, and cognitively impaired individuals who are unable to provide informed consent

Keywords: ccsvi
a case control study to define clinical, immunologic and radiographic features of the aromatase inhibitor arthralgia syndrome

Conditions: Arthralgia Syndrome; Arthritis; Synovitis

Summary: the ciras study will investigate postmenopausal breast cancer patients with hand pain and compare those receiving aromatase inhibitors (cases) to breast cancer patients with hand pain not receiving aromatase inhibitors (controls) in order assess whether this syndrome is an inflammatory arthritis.

this study is for women with post-menopausal breast cancer and hand pain. patients do not need to be taking aromatase inhibitors to be eligible for the study. we want to study the joint findings in patients with hand pain and breast cancer undergoing treatment with aromatase inhibitor medications and compare them to patients with hand pain and breast cancer not treated with these medications. aromatase inhibitor drugs are used in certain types of breast cancer to reduce the risk of cancer returning after treatment. one of the side effects of aromatase inhibitors is the development of joint pain, a complication known as the arthralgia syndrome. the cause of the arthralgia syndrome is not known, but we suspect that the pain may be due to inflammation in the joints. currently, the only effective treatment is to stop the aromatase inhibitor, and so affected patients may miss out on an otherwise useful treatment to prevent return of their cancer. post-menopausal patients with breast cancer and hand pain can enroll in the study. patients will be asked to come for a separate visit which will take about half a day.

Eligibility criteria:
inclusion criteria: 1. postmenopausal women aged over 18 with stage i-iii breast cancer undergoing treatment at the lombardi cancer center. 2. presence of hand pain 3. no active signs of ongoing malignant disease exclusion criteria: 1. known autoimmune disease for example, rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, or seronegative arthritis. 2. age \<18 3. unable to complete informed consent process

Keywords: arthritis synovitis aromatase inhibitor arthralgia syndrome
comprehensive voice rehabilitation program compared with vocal function exercises

Conditions: Dysphonia

Summary: the purpose of this study is to evaluate the effectiveness and safety of the comprehensive voice rehabilitation program compared with vocal function exercises in behavioral dysphonia.

introduction: voice therapy is the best indication for the most voice disorders, with a strong degree of recommendation based on systematic reviews and randomized clinical trials, with a predominance of benefit over risk. some speech therapy techniques are specific, others are organized principles or with eclectic approaches, that use a combination of strategies. so far, few studies have tested the effectiveness of treatment for dysphonia due to time spent, safety and improved quality of life more comprehensive as they are made in clinical. objective: to evaluate the effectiveness and safety of the comprehensive voice rehabilitation program compared with vocal function exercises in behavioral dysphonia. methods: 106 professional of voice with dysphonia behavior, between 18 and 50 years old and vocal complaints for more than six months. these professionals have been evaluated by an otolaryngologist, randomized to participate of vocal function exercises arm or comprehensive voice rehabilitation program arm. both arms were follow for six sessions with speech therapists and reassessed when finish the period and after one month. the primary outcomes assessed are: reduction of vhi score, improved voice quality in the cape-v and improves the larynx condition. conclusions: the comprehensive voice program has an eclectic approach and follows the philosophy of what is practiced in clinics in brazil. we believe this program can demonstrate the power of voice therapy effectiveness more organized to solve problems, with shorter duration of treatment, benefit patient health and funding agencies such as unified public health system (sus) and health insurance.

Eligibility criteria:
inclusion criteria: * voice professionals with behavioral dysphonia, with or without larynx lesions, with otorhinolaryngologist's indication; * over 6 months with vocal complain; * 3 or more signs and symptoms in the questionary. exclusion criteria: * other kind of vocal disorder, speech or language disorder, malignant lesions, hormonal disturbances related by the patient, laryngeal papilloma, etc. * singers; * neurological problems; * acute larynx problem.

Keywords: voice disorders hoarseness therapy
a study of rc48-adc combined with js001 for postoperative adjuvant treatment of upper tract urothelial carcinoma

Conditions: Carcinoma; Upper Tract Urothelial Carcinoma; UTUC

Summary: this study will evaluate the efficacy and safety of intravenous rc48-adc combined with js001 in postoperative adjuvant therapy for her2-positive upper tract urothelial carcinoma.

this is an open-label, single-arm clinical trial to evaluate the efficacy and safety of rc48-adc, a recombinant humanized anti-her2 monoclonal antibody-monomethyl auristatin e (mmae) conjugate, in combination with js001, a pd-1 monoclonal antibody, for the postoperative adjuvant treatment of her2-positive upper tract urothelial carcinoma after radical nephroureterectomy.

Eligibility criteria:
inclusion criteria: * written informed consent * ≥18 years of age * post radical nephro-ureterectomy for upper tract tumour with predominant tcc component-squamoid differentiation or mixed tcc/scc is permitted. * histologically confirmed tcc staged pt2-pt4 pn0-2 m0 or ptany n1-2 m0 (providing all grossly abnormal nodes are resected). * pathological tissue immunohistochemistry her2 2\~3+ * fit and willing to receive adjuvant therapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated * ecog(eastern cooperative oncology group) performance is 0\~2. * available for long-term follow-up exclusion criteria: * evidence of distant metastases * pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology * un-resected macroscopic nodal disease * concurrent muscle invasive bladder cancer (patients with concurrent non-muscle invasive bladder cancer (nmibc) will be eligible) * significant co-morbid conditions that would interfere with administration of protocol treatment * pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active); * previous malignancy in the last 5 years except for previous nmibc, adequately controlled non melanoma skin tumours, cis of cervix or lcis of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.
study of policosanol to improve platelet reactivity after percutaneous coronary stent implantation (pci)

Conditions: Coronary Artery Disease

Summary: thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death. even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice the aim of this multicenter prospective, randomized, controlled study is to observed policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after percutaneous coronary stent implantation (pci) and occurrence of platelet aggregation and short-term prognosis to find new ways to the prevention of platelet aggregation .

thrombotic event is one of the most serious complications in coronary artery disease, which often result in myocardial infarction and even death. even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice

Eligibility criteria:
inclusion criteria: * patients with coronary heart disease and had received coronary stenting * high on-treatment platelet reactivity defined as an adp-induced platelet aggregation (by lta)\> 65% at 24 hr after clopidogrel loading (300 \~ 600mg)or 5 days after maintenance dose treatment (75mg / d) * informed consent exclusion criteria: * receiving gp iib / iiia receptor antagonist treatment within 24h before enrollment * using cilostazol within 7d before enrollment * aspirin, clopidogrel or policosanol allergies * nyha grade iii \~ iv * planned elective coronary revascularization for multivessel coronary artery disease * long term warfarin treatment after persistent atrial fibrillation, valve surgery or other circumstance * severe liver or kidney dysfunction * active ulcer or a history of recent gastrointestinal bleeding * history of coagulation disorder, or recent history of active bleeding * history of intracranial hemorrhage within 6 months * pregnancy * ldl less than 70mg/dl * severe systemic diseases with life expectancy less than 1 year * planned surgery within next 6 months

Keywords: high on-treatment platelet reactivity percutaneous coronary intervention stent thrombosis
observational study of novopen® 4 on treatment satisfaction of insulin therapy in type 1 or type 2 subjects with diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this study is conducted in asia. the aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using novopen® 4 under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * any subject with type 1 or type 2 diabetes and accepting to use novopen® 4. the selection will be at the discretion of the individual physician. * a study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations exclusion criteria: * subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit * subjects with known or suspected allergy to any insulin or any of its excipients
an infraclavicular landmark-based approach to the axillary vein

Conditions: Critical Illness

Summary: the central line placement is the widespread procedure performed in the intensive care and emergency medicine. indications for this procedure are chiefly lack of peripheral catheters, administration some medications, renal replacement therapy, parenteral nutrition and hemodynamic monitoring. the procedure is performed by percutaneous puncture of large vein of the neck and the thorax - internal jugular vein or subclavian vein, then insertion of guidewire through the needle and placement of the catheter over the guidewire. the tip of the catheter is situated in the superior vena cava. there are two techniques of catheterizations: landmark-based and ultrasound-guided. the most frequently cannulated veins in landmark-based approach are internal jugular and subclavian vein. the cannulation of the axillary vein is not common procedure in the intensive care unit, mainly due its complicated original technique. the primary intention of this study was to describe and assess usefulness and safety of the new landmark-based technique of catheterization of the axillary vein in patients admitted to the intensive care unit.


Eligibility criteria:
inclusion criteria: * patients admitted to the intensive care unit with indications for central venous catheterization exclusion criteria: * chest wall deformities at the cannulations side * major hemostasis disorders * infections at the catheterization site * age less than 18 years * lack of patients consent

Keywords: critical care catheterization axillary vein
azd1386 japanese multiple ascending dosing study

Conditions: Chronic Pain

Summary: this is a single centre, double-blind, randomised, parallel group, placebo controlled study to assess the safety, tolerability and pharmacokinetics of azd1386 when given as multiple doses to 32 (24 healthy young and 8 healthy elderly) japanese subjects. for young healthy subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are planned. for elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is planned.


Eligibility criteria:
inclusion criteria: * healthy japanese males or females young (≥20 to ≤45 years inclusive) or elderly (≥65 to ≤80 years inclusive). female subjects must be surgically sterile or post-menopausal. * body mass index (bmi) of ≥19 to ≤ 27 kg/m2 and weight of ≥45 to ≤90 kg * clinically normal physical findings including heart rate \> 45 bpm and laboratory values and normal resting ecg exclusion criteria: * history of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator * a family history of short or long qt syndrome (sqts) or sudden cardiac death (scd) amongst first degree relatives * subjects with orthostatic hypotension defined as a decrease of ≥ 25mmhg systolic blood pressure and/or a decrease of ≥15mmhg diastolic blood pressure within 5 minutes when going from a supine to standing position * clinically significant illness or clinically relevant trauma within 2 weeks prior to the administration of the investigational product as judged by the investigator

Keywords: japanese mad multiple ascending dose chronic pain